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MAGNAIR

™

NEBULIZER SYSTEM INSTRUCTIONS FOR USE

For use with

LONHALA™ (glycopyrrolate) Inhalation Solution only

Warning

Read and understand the full Patient Information (PI) for information and

warnings related to LONHALA. The PI is contained in the LONHALA box.

Warning

Read and understand these

Instructions for Use

and all safety precautions

it contains. Improper use can cause serious or fatal injury/illness.

Assembly required. LONHALA vials packaged separately.

Marketed by:

Содержание Lonhala Magnair

Страница 1: ...nd the full Patient Information PI for information and warnings related to LONHALA The PI is contained in the LONHALA box Warning Read and understand these Instructions for Use and all safety precautions it contains Improper use can cause serious or fatal injury illness Assembly required LONHALA vials packaged separately Marketed by ...

Страница 2: ...eps for Using Batteries or AC Adapter with MAGNAIR 6 D Assembling Your MAGNAIR 8 E Using LONHALA MAGNAIR 11 F Cleaning the Handset 15 G Troubleshooting 20 H Specifications 23 Intended Use and Authorized Users MAGNAIR is intended for single patient use in the delivery of LONHALA to patients who self administer treatments or have treatments administered by a caregiver or health care provider MAGNAIR...

Страница 3: ...is intended for Single Patient Use Only Do not share your MAGNAIR with anyone else 2 MAGNAIR is designed specifically for use only with LONHALA To reduce the risk of severe or fatal injury illness Never use other medications in MAGNAIR 3 Read and follow all warnings and instructions in the Instructions for Use prior to using this device 4 To reduce the risk of serious or fatal injury from electroc...

Страница 4: ...t parts after each treatment Follow the instructions in Section F to clean the MAGNAIR Handset properly 11 Cleaning the MAGNAIR Handset properly will help prevent the Aerosol head from clogging If the Aerosol head becomes clogged the aerosol mist may be reduced altered or stopped which could increase the nebulization time up to 15 minutes and or diminish the effectiveness of the treatment Do Not S...

Страница 5: ...to make sure you have all of the following MAGNAIR parts and become familiar with how to identify each piece If any parts are missing call the Sunovion Customer Service line 1 888 394 7377 See Fig B1 Fig B1 MAGNAIR Nebulizer System Controller Medication cap Handset body Mouthpiece 4 AA batteries AC adapter Aerosol head Connection cord LONHALA vials packaged separately Carrying bag ...

Страница 6: ...ries or with the AC adapter Four 4 high quality AA batteries will provide approximately 2 weeks of treatment C1 Open the battery door on the Controller by placing your thumb on the black tab of the battery door and firmly pushing the tab to open the door Note that the battery door is designed to have a tight fit See Fig C1 C2 Load the batteries Each battery chamber has a small figure that shows th...

Страница 7: ...eries if you plan to store the Controller for more than 30 consecutive days C4 Plug the AC adapter into the Controller To connect the AC adapter to the Controller place the Controller on a flat stable surface The inlet is located on the underside of the black battery door Push the round end of the AC adapter cord into the inlet Do Not try to insert the AC adapter into the blue colored part of the ...

Страница 8: ...ead in the Handset body after use and Do Not use dirty or damaged parts because this can impair the function of the Handset D1 Wash your hands Fig D2 Open the Handset body D2 Open the top of the Handset body Lift the clasp on top of the Handset body slightly and flip it up to open See Fig D2 Fig D3 Insert the Aerosol head into the Handset body Do not touch the center of the Aerosol head D3 Insert ...

Страница 9: ...ompletely or align the Aerosol head correctly your medication may leak and you will not get your full treatment See Fig D4 Do not force the top of the Handset body closed If the top of the Handset body cannot close no Click is heard make sure that the Aerosol head is seated correctly and level D ASSEMBLING YOUR MAGNAIR cont Fig D5 Attach the Mouthpiece D5 Attach the Mouthpiece to the Handset body ...

Страница 10: ... Click if inserted correctly See Fig D6a Fig D6b Connect the other end of the Connection cord to the Handset body D6b Connect the Controller to the Handset body using the Connection cord as shown The other end of the Connection cord is blue and gray Insert the Connector with gray mark facing up into the Handset body as far as it will go ensuring the gray mark on the Connection cord lines up with t...

Страница 11: ...e in the Carrying bag to be used at the next treatment Discard the vial if not used within 7 days See Fig E1 E2 Insert 1 LONHALA vial into the Medication cap The Medication cap has a top and a bottom Insert a LONHALA vial with the flat tab first through the bottom of the Medication cap and press it in as far as it will go You should hear a Click if the LONHALA vial was inserted correctly See Fig E...

Страница 12: ... and you will not get your full treatment Place the Medication cap with the LONHALA vial on top of the Handset body See Fig E3b Turn the Medication cap in a clockwise direction As you turn the Medication cap the LONHALA vial will open and you should hear a Click The notch at the base of the opening in the Medication cap should line up with the blue line on the Handset body See Fig E3c E USING LONH...

Страница 13: ...hpiece into your mouth and seal your lips around it Do Not tilt the Handset Make sure the Handset is level Do Not cover the blue valve with your lips Do Not Loosen or remove the Medication cap until your treatment is complete because your medication could leak and you will not get your full treatment See Fig E4 E5 Turn on the Controller Press the On Off button to start your treatment A green LED l...

Страница 14: ...gh the Mouthpiece until the Controller Beeps and shuts off To pause your treatment press the On Off button To continue your treatment press the On Off button again See Fig E5 E7 At the end of treatment the Controller will automatically shut off When all of the medication has been delivered you will hear 2 Beeps the green LED light will turn off and the Controller will automatically shut off Your t...

Страница 15: ...or antibacterial liquid dish soaps as these may contain additives harmful to the Aerosol head Do Not leave the Aerosol head in your Handset Do Not wash the Controller Connection cord or AC adapter Caution Do Not put MAGNAIR parts into a microwave oven Do Not clean the MAGNAIR parts in a dishwasher Do Not clean the Aerosol head and Handset parts with brushes or abrasives CLEANING THE HANDSET Fig F1...

Страница 16: ... push up as shown to remove the LONHALA vial Throw away the LONHALA vial into wastebasket See Fig F3 F CLEANING THE HANDSET cont Fig F4 Remove the Mouthpiece F4 Remove the Mouthpiece from the Handset body by giving it a gentle twist and pull to separate from the Handset body See Fig F4 Fig F5 Loosen the blue valve F5 Loosen the blue valve Carefully loosen the blue valve from the slot in the Mouthp...

Страница 17: ...seconds F7 Rinse each of the disassembled Handset parts well under warm above 105 F running tap water approx 10 seconds See Fig F7 F8 Wash all Handset parts in warm above 105 F soapy water made by adding a few drops teaspoon of clear liquid dishwashing soap into a bowl 1 quart of clean warm tap water Swish the Handset parts around in the soapy water to clean See Fig F8 Do Not wash the Connection c...

Страница 18: ...10 seconds on each side 10B Wash the Aerosol head by holding the handle and swishing it back and forth in the warm soapy water for about 10 seconds 10C Rinse both sides of the Aerosol head well with warm running water for about 10 seconds on each side Rinsing the Aerosol head well helps prevent clogging and ensures proper operation Do Not add dishwashing liquid directly onto the Aerosol head add t...

Страница 19: ...a dry clean lint free towel and allow them to air dry Do Not dry using a paper towel Do Not touch the center of the Aerosol head See Fig F12 F13 Store disassembled Handset parts After the Handset parts are completely dry place them in the provided Carrying bag or a dry dust free environment for storage Do Not put the Handset parts back together until ready to use again for your next treatment of L...

Страница 20: ... Two Beeps occurred immediately after starting No drug detected Two tone Beep occurred 10 30 seconds after starting Check connection between the Controller and the Handset Check to confirm a LONHALA vial has been inserted and the Handset clasp is closed properly Tilt the Handset from side to side then tap the Handset to dislodge LONHALA and restart the Controller 4 1 Brief Beep LED starts green th...

Страница 21: ...off after a few seconds Low power Check for bad batteries Missing or improper insertion assembly of LONHALA vial Confirm that a new LONHALA vial has been inserted Tap MAGNAIR slightly to move the liquid to the bottom of the LONHALA vial If aerosol mist is still not generated after MAGNAIR has been restarted the LONHALA vial may not have been pierced or is empty Replace the vial if empty If partial...

Страница 22: ...opened throw away the LONHALA vial rinse and dry the Handset parts then insert a new vial 3 If the LONHALA vial has not been opened place the Medication cap back on the Handset and turn the Medication cap containing your LONHALA vial in a clockwise direction until it clicks then restart your treatment by pressing the On Off button 10 Increasing or long inhalation time 1 Treatment time may vary up ...

Страница 23: ...ne stainless steel thermoplastic elastomers Does not contain any natural rubber latex DISPOSAL The MAGNAIR parts and batteries must be thrown away in accordance with local state county or municipal regulations PERFORMANCE CHARACTERISTICS LONHALA glycopyrrolate Inhalation Solution 25 mcg mL Mean1 95 Confidence Range2 Delivered dose by breath simulation mcg 14 20 11 11 17 29 Delivered dose by breath...

Страница 24: ...011R01 LONHALA and are trademarks of Sunovion Pharmaceuticals Inc MAGNAIR is a trademark of PARI Pharma GmbH used under license SUNOVION and are registered trademarks of Sumitomo Dainippon Pharma Co Ltd Sunovion Pharmaceuticals Inc is a U S subsidiary of Sumitomo Dainippon Pharma Co Ltd PARI and are registered trademarks of PARI GmbH eFlow is a registered trademark of PARI Pharma GmbH Made under l...

Страница 25: ...n be read by the end user It is the Supplier s option to use the codes as supplied or to replace with a new code that is modified to better meet press requirements Document Information File name 902011R01_05Dec17_r67 indd MID 902011R01 Software InDesign CC2015 Flat Size 16 5 in x 11 in Folded Size 8 25 in x 11 in PARI A N 578D2000 B Design Firm Job 19702 Op dl rs tk dl rs dl dl sb rs eb rs dl Barc...

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